The UK continues to have a system of adverse drug reaction monitoring which is claimed by some to be excellent but which is known to be inadequate. Dr Bill Inman, a retired Professor of Pharmacoepidemiology, University of Southampton, UK, pioneered the system of spontaneous reporting of adverse drug reactions (‘yellow card’) and of prescription event monitoring. The Yellow Card scheme was a response to the 1960s Thalidomide drug scandal which left many children born with serious deformities including no arms or legs.

The Yellow Card system could long ago have been improved but was not. For example Dr Inman considered that there are no national systems in place which might prevent another tragedy like thalidomide: for which a database of pregnant women’s drug histories is critical. The lack of medium-term and long-term (25 years) follow-up for cancer treatments was another concern and he thought the World Health Organistion should be more active in that: “Profile of Bill Inman – Yellow Cards and Green Forms WHO Uppsala Reports 27 October 2004” http://www.who-umc.org

What Was Meant to Happen in the UK

UK pilot trials for direct patient reporting were announced on 18 November 2002 by what is now the MHRA:

Lord Hunt [a Health Minister] …. announced his intention to introduce a scheme to allow patients to report adverse reactions through NHS Direct and NHS Direct Online in the New Year.”

Professor Alasdair Breckenridge, Chairman of the Committee on Safety of Medicines, said in relation to the extension of the Yellow Card scheme to nursing and other staff:

Doctors up and down the country know the Yellow Card goes hand in hand with improving what we know about drugs and how they are used. And now a new generation of reporters to the scheme – nurses, midwives and health visitors, including nurse prescribers, in the frontline of patient care – will be able to play a full part in making sure that we keep learning and that patients benefit from experience.’

Six months later on 8th May 2003, another MHRA press release stated:

Health Minister David Lammy has announced the first phase of patient reporting of suspected Adverse Drug Reactions (ADRs) via NHS Direct.

The NHS Direct call centre in Beckenham, covering South East London, has become the first centre in the country to introduce patient reporting of ADRs.

Subject to experience at the first call centre, the intention is to roll out the new service to all 22 NHS Direct call centres throughout England.”

Minister David Lammy was quoted:

Today marks an important step in putting patients in England at the heart of systems for promoting and protecting public healthcare by enabling them for the first time to report suspected ADRs.

Rather than having to go to a GP, patients can quickly access advice and report reactions that can help to improve our knowledge of the safe use of medicines.’

Professor Alasdair Breckenridge who was by then the chairman of the MHRA, was also quoted in the press release as saying:

The Yellow Card Scheme has been the cornerstone of monitoring drug safety for nearly 40 years.

We now plan to roll out across England a new service offered by NHS Direct.

This will enable patients to contribute directly to the Yellow Card scheme by reporting their own ADRs. We will be carefully monitoring the results of this pilot.”

[Professor Alasdair Breckenridge was previously the Chairman of the Committee on Safety of Medicines. The MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA).]

What Really Happened

The MHRA under Professor Breckenridge’s Chairmanship wrested control of direct patient reporting of adverse drug reactions from the NHS and well and truly buried it.

The pilot trial was for the whole of SE London using what was then the NHS Direct call centre in Beckenham, Kent. There were only 39 responses for the whole of South-East London in an entire year.

Dr Metters, the Chairman of the ‘independent’ review of the trial was reported in the British Medical Journal saying:

We can only speculate why participation has been so poor”

The truth was it was extensively unpublicised. The MHRA, in the person of Miss Carrie Scott Pharmacovigilance Co-ordinator Room 15-259 in a letter of 11th June 2004 ref: OG 04/43 to Social Audit admitted hardly anything had been spent promoting this scheme. In the letter she wrote:-

The MHRA has not incurred any significant costs due to this initiative. Advertising regarding the Scheme was limited to local press coverage. Due to the small number of reports received no costs were incurred in terms of staff resource.”

This was to cover the whole of South East London, an area with a population of several million people, and yet no significant costs were incurred. Not even the local Beckenham GP surgeries or pharmacies appear to have had heard of it until some local GPs read an abridged news item in the paper version of the BMJ published Saturday 8th May 2004. There were no posters in doctor’s surgeries or pharmacies; no patient ‘How To Report’ leaflets; nothing.

The MHRA published FAQ, items 16-19 and particularly item 17 stated:-

the number of reports [39] suggests the Scheme is not universally popular and anecdotal feedback suggests patients would prefer to report direct to the MHRA.”

There were only 39 reports because hardly anyone knew about the scheme.

But Metters and others should not have been surprised by this. Hardly anybody in the area had heard of the scheme – not even doctors or pharmacists. As one resident said: “My own local GP surgery did not know about it until they read about it in last week’s BMJ.” And as a pharmacist put it: “What scheme? Never heard of it.”

The current next-to-useless drug safety system whereby doctors fill in a yellow card if they suspect a drug or vaccine has caused an adverse reaction, certainly needs improving: it picks up only a tiny fraction of bad reactions.

While NHS Direct would have been an ideal body to collate reports of adverse incidents Metters and colleagues have seized on Beckenham’s “poor response” and suggested that reporting might be improved if patients have direct access to the new Medicines and Healthcare Products Regulatory Agency (MHPA). Unfortunately this would mean that information, and control of that information, would go straight to the body which, with its advisory arm, the Committee on the Safety of Medicine, has been criticised for its secrecy, conflicts of interest and past failings.

Key figures on both bodies have consultancy research, financial or employment links with the big drug companies. For example, the MRHA’s top man is Professor Sir Alasdair Breckenridge, who used to advise GlaxoSmithKline, the manufacturer of the antidepressant Seroxat. It was the failure of the drug regulators to warn doctors earlier about potential problems associated with Seroxat that led to the recent resignation in protest of Richard Brook, the lay member on the CSM.

The scandal prompted Charles Medawar of consumer group Social Audit and author of Medicines Out Of Control to suggest that it was Sir Alasdair who should have resigned. But he didn’t.

The MHRA also announced:

The MHRA intends to get direct patient reporting up and running as soon as possible.”

But it was already up and running, at NHS Direct. All they needed to do was tell people about it like notifying the GPs and pharmacies and produce the leaflets and publicise it.

As Social Audit noted, there was still after the MHRA intervened with their own system no provision for direct patient reporting via the electronic yellow card scheme. The Scheme invites reports from by doctors, dentists, pharmacists, coroners, radiographers, optometrists and nurses, and expressly confirms no provision has been made for direct patient reporting.

It is not sound to put the MHRA in charge of the information which can show it has been failing in its duties to protect the public. But that is what happened and the MHRA played its part in making that happen.

One Response

Giving Big Pharma the job of self-regulating adverse reactions is very sensible and trusting of our government. It is of course totally unscientific and counter intuitive. But when have these concerns ever guided political judgement?